Vascular remodeling device

ABSTRACT

Described herein are flexible implantable devices or stents that can conform to the shape of vessels of the neurovasculature. In some embodiments, the devices can direct blood flow within a vessel away from an aneurysm or limit blood flow to the aneurysm. In some embodiments, a vascular remodeling device includes a first section and a protruding section. During deployment, the device expands from a compressed configuration to an expanded configuration. The first section anchors the device in an afferent vessel and/or in an efferent vessel of a bifurcation and the protruding section is positioned in the junction of the bifurcation having an aneurysm and across the neck of the aneurysm or at least partially within the aneurysm.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/611,647, filed Feb. 2, 2015, which is a continuation of U.S.application Ser. No. 13/469,214, filed May 11, 2012, now issued as U.S.Pat. No. 8,956,399 on Feb. 17, 2015, which claims priority to U.S.Provisional Patent Application No. 61/485,063, filed on May 11, 2011,each of the above applications hereby being expressly incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The present application generally relates to implantable devices for usewithin a patient's body and, more particularly, relates to methods forimplanting occluding devices, such as stents, in a patient's body andmonitoring an occlusion.

BACKGROUND

Lumens in a patient's body can change in size, shape, and/or patency,and such changes can present complications or affect associated bodilyfunctions. For example, the walls of the vasculature, particularlyarterial walls, may develop a pathological dilatation, commonly calledan aneurysm. Aneurysms are observed as a ballooning-out of the wall ofan artery. This is a result of the vessel wall being weakened bydisease, injury, or a congenital abnormality. Aneurysms have thin, weakwalls and have a tendency to rupture and are often caused or made worseby high blood pressure. Aneurysms can be found in different parts of thebody; the most common being abdominal aortic aneurysms (AAA) and thebrain or cerebral aneurysms. The mere presence of an aneurysm is notalways life-threatening, but an aneurysm can have serious healthconsequences such as a stroke if one should rupture in the brain.Additionally, a ruptured aneurysm can also result in death.

SUMMARY

In some embodiments, described herein are embodiments of a vascularstent that includes a proximal section having a first cross-sectionaldimension and being configured to anchor in an afferent vessel of abifurcation proximate to an aneurysm, the proximal section comprising atubular shape that defines a proximal lumen; a distal section having asecond cross-sectional dimension and being configured to be positionedin an efferent vessel of the bifurcation, the distal section comprisinga tubular shape that defines a distal lumen; and a protruding section,between the proximal and distal sections, having a third cross-sectionaldimension, the protruding section (i) being configured to abut an ostiumof the aneurysm when the protruding section is positioned at thebifurcation, (ii) defining an intermediate lumen in fluid communicationwith the proximal and distal lumens, and (iii) having a strut patternthat is substantially the same as strut patterns of the proximal anddistal sections. In some embodiments, the proximal, distal andprotruding sections are expandable from a compressed configuration to anexpanded configuration.

Some embodiments provide that the protruding section is configured toinhibit dislodgment of objects out of the aneurysm. In some embodiments,the strut patterns of the proximal, distal, and protruding sectionsdefine substantially similar cell sizes. In certain embodiments, cellsizes of the strut pattern in the protruding section are configured toallow perfusion of fluid to efferent vessels. In some embodiments, theproximal, distal, and protruding sections comprise nonuniformcross-sectional dimensions when the stent is unconstrained. Someembodiments provide that the protruding section comprises anirregular-shaped cross-section.

In some embodiments, the protruding section is expandable to a furtherexpanded configuration, the further expanded configuration defining afourth cross-sectional dimension greater than the third cross-sectionaldimension. In some embodiments, the proximal, distal, and protrudingsections comprise woven filaments. Some embodiments provide that atleast one of the proximal, distal, and protruding sections isself-expandable. In some embodiments, at least one of the proximal anddistal sections comprises a first material and the protruding sectioncomprises a second material different from the first material.

In certain embodiments, the stent further includes (i) a firstintermediate section, between the proximal and protruding sections,having a first taper, from the proximal section to the protrudingsection, and (ii) a second intermediate section, between the distal andprotruding sections, having a second taper, from the distal section tothe protruding section, the first taper having a different degree oftapering than the second taper. In some embodiments, the second taperhas a steeper degree of tapering than does the first taper.

In some embodiments, the protruding section bulges radially outwardalong substantially an entire circumference of the device. In certainembodiments, a bulge of the protruding section provides a generallyasymmetrical profile. Some embodiments provide at least a portion of theprotruding section comprises a lower filament density than at least oneof another portion of the protruding section, the proximal section, andthe distal section.

Some methods described herein for treating an aneurysm at a junction ofa bifurcation, having first and second efferent vessels, includeadvancing a catheter to the first efferent vessel of the bifurcation;advancing, relative to and within the catheter, a stent in a compressedconfiguration, the stent comprising (i) a proximal section having afirst cross-sectional dimension and a tubular shape that defines aproximal lumen, (ii) a distal section having a second cross-sectionaldimension and a tubular shape that defines a distal lumen; and (iii) aprotruding section, between the proximal and distal sections, having athird cross-sectional dimension and defining an intermediate lumen influid communication with the proximal and distal lumens, the protrudingsection having a strut pattern that is substantially the same as strutspatterns of the proximal and distal sections; expanding, to an expandedconfiguration, the proximal and distal sections to anchor the stent inthe efferent and an afferent vessel; and expanding the protrudingsection at the bifurcation, such that the protruding section abuts anostium of the aneurysm and inhibits dislodgment of objects out of theaneurysm. In some methods, after the expanding steps, the proximal,intermediate, and distal lumens provide a substantially unobstructedpath for fluid flow from the afferent vessel to the first efferentvessel and the strut pattern of the protruding section permits fluidflow to the second efferent vessel.

In certain methods, at least one of the proximal, distal, and protrudingsections self-expands. Some methods further include withdrawing thestent at least partially back into the catheter after a portion of thestent has been advanced out of the catheter.

Some methods further include inserting embolic material into theaneurysm. In some methods, embolic material is inserted into theaneurysm before sections of the stent are expanded. In certain methods,embolic material is inserted into the aneurysm after sections of thestent are expanded. In some methods, embolic material is inserted intothe aneurysm through a wall of the stent defined by the strut pattern ofthe protruding section.

Some methods described manufacturing of a vascular device, and somemethods include forming a substantially tubular stent having asubstantially similar strut pattern throughout the stent; shape settingthe stent to form (i) a proximal section having a first cross-sectionaldimension and a proximal lumen and (ii) a distal section having a secondcross-sectional dimension and a distal lumen; and shape setting thestent to form a protruding section, between the proximal and distalsections, having a third cross-sectional dimension greater than thefirst and second cross-sectional dimensions, wherein the proximalsection is configured to anchor in an afferent vessel of a bifurcationcomprising an aneurysm, the protruding section is configured to bepositioned at the bifurcation and to act as a scaffolding to inhibitdislodgment of objects out of the aneurysm by abutting an ostium of theaneurysm, and the distal section is configured to be positioned in anefferent vessel of the bifurcation. In some methods, the proximal,intermediate, and distal lumens are configured to provide asubstantially unobstructed fluid flow path from the afferent vessel tothe efferent vessel.

In some methods, the forming includes cutting a tube. In some methods,the forming includes cutting a sheet and shape setting the sheet into asubstantially tubular shape. In some methods, the forming includesweaving a plurality of wires and shape setting the plurality of wiresinto a substantially tubular shape.

In certain methods, the strut pattern defines substantially similar cellsizes. Certain methods further include shape setting (i) a firstintermediate section, between the proximal and protruding sections,having a first taper, from the proximal section to the protrudingsection, and (ii) a second intermediate section, between the distal andprotruding sections, having a second taper, from the distal section tothe protruding section, the first taper having a different degree oftapering than the second taper. In some methods, the second taperedportion is formed to have a steeper degree of tapering than does thefirst tapered portion.

In another aspect of the disclosure, a method of treating an aneurysm ata junction of a bifurcation having an afferent vessel and efferentvessels is disclosed. The aneurysm may have a neck and a fundus. Themethod may include advancing a catheter to a first efferent vessel ofthe bifurcation. The method may also include advancing, relative to andwithin the catheter, a vascular device in a compressed configuration.The device may include a first section configured to anchor in at leastone of the afferent vessel and the first efferent vessel, and aprotruding section coupled to the first section and being configured toinhibit protrusion of objects out of the aneurysm. The method mayfurther include allowing the vascular device to expand to an expandedconfiguration as the vascular device is advanced out of the catheter,and allowing the protruding section to expand to a further expandedconfiguration at the junction of the bifurcation. The first section mayhave a first transverse dimension in the expanded configuration and theprotruding section may have a second transverse dimension in the furtherexpanded configuration. The second transverse dimension may be greaterthan the first transverse dimension.

In some embodiments, the method may further releasing the vasculardevice from the catheter. Releasing the vascular device from thecatheter may include mechanical detachment, electrolytic detachment,and/or chemical detachment.

In some embodiments described herein, the protruding section may beconfigured to reduce an effective width of a neck of the aneurysm. Insome embodiments, the protruding section may bulge radially outwardalong substantially an entire circumference of the device. In otherembodiments, the protruding section may bulge radially outward along aportion of a circumference of the device. In yet other embodiments, thebulge of the protruding section provides a generally symmetricalprofile. In yet other embodiments, the bulge of the protruding sectionprovides a generally asymmetrical profile. In yet other embodiments, theprotruding section bulges outwardly towards a line or a point. Infurther embodiments, the protruding section bulges outwardly in asubstantially rounded manner.

In some aspects of the disclosure, a method of manufacturing a vasculardevice is disclosed. The method may include forming a substantiallytubular device, and shape setting the tubular device to form a firstsection having a first transverse dimension. The method may furtherinclude shape setting the tubular device to form a protruding sectionhaving a second transverse dimension. The second transverse dimensionmay be greater than the first transverse dimension. The first sectionmay be configured to anchor in a vessel of a bifurcation that has ananeurysm. The protruding section may be configured to act as ascaffolding to inhibit protrusion of objects out of the aneurysm. Atleast one of the first section and the protruding section may beconfigured to allow perfusion of fluid to efferent vessels.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the subject technology and are incorporated in andconstitute a part of this specification, illustrate aspects of thedisclosure and together with the description serve to explain theprinciples of the subject technology.

FIG. 1A illustrates an exemplary vascular remodeling device, accordingto one or more embodiments disclosed.

FIG. 1B illustrates an enlarged view of the vascular remodeling deviceshown in FIG. 1A, according to one or more embodiments.

FIG. 2A illustrates an exemplary vascular remodeling device having aprotruding section, according to one or more embodiments.

FIG. 2B illustrates another exemplary vascular remodeling device havinga protruding section, according to one or more embodiments.

FIG. 2C illustrates another exemplary vascular remodeling device havinga protruding section, according to one or more embodiments.

FIG. 3A illustrates an exemplary vascular remodeling device in itsexpanded configuration, according to one or more embodiments.

FIG. 3B illustrates the vascular remodeling device of FIG. 3A having theprotruding section in its further expanded configuration, according toone or more embodiments.

FIG. 4A illustrates an exemplary vascular remodeling device as deployedat a bifurcation having efferent vessels and an aneurysm, according toone or more embodiments disclosed.

FIG. 4B illustrates the exemplary vascular remodeling device of FIG. 4Awhere the protruding section acts as scaffolding, according to one ormore embodiments disclosed.

FIG. 5 illustrates an exemplary vascular remodeling device as deployedat a bifurcation having an aneurysm, according to one or moreembodiments disclosed.

FIGS. 6A, 6B, 6C, 6D, 6E, 6F, 6G, 6H, 6I, 6J, 6K, 6L illustrateexemplary cell patterns that may be employed on the various vascularremodeling devices described herein, according to one or moreembodiments disclosed.

FIGS. 7A and 7B illustrate exemplary vascular remodeling devices usingvarious cell patterns, according to one or more embodiments disclosed.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. It willbe apparent, however, to one ordinarily skilled in the art that thesubject technology may be practiced without some of these specificdetails. In other instances, well-known structures and techniques havenot been shown in detail so as not to obscure the subject technology.

Referring now to FIGS. 1A and 1B, illustrated is an exemplary vasculardevice 53, according to one or more embodiments of the disclosure. Thevascular device 53 may be characterized as an occluding device, such asa vascular occluding device, or a stent and may be used generally invascular remodeling applications. The device 53 is movable between acompressed configuration and an expanded configuration and includes afirst section 55 and a second, or protruding section 57. The device 53may comprise one or more additional sections, such as a third sectionadjacent to the protruding section 57 on a side thereof opposite thefirst section 55. A third section may have characteristics similar orequal to the first section 55, as disclosed herein. In some embodiments,the device 53 is more compliant than the vasculature in which it isdeployed such that it may be somewhat misshapen once deployed in thevasculature or otherwise conform to the general shape of thevasculature, and that certain protruding shapes described herein areachievable when the device 53 is an expanded configuration with norestriction.

The first section 55 may be characterized as an “in-vessel section,”“main body,” “stem,” “tubular portion,” or “anchoring section.” Thesecond or protruding section 57 may be characterized as a “scaffoldingsection,” “bulging or pregnant section,” or “extruded section.” In oneor more embodiments, the device 53 may be delivered via an elongate body(not shown), such as a catheter or microcatheter, into a bifurcation inorder to support an aneurysm filling device with minimal interruption ofblood flow in afferent and/or efferent vessels. In some embodiments, thedevice 53 may be retrievable and/or repositionable, without departingfrom the scope of the disclosure.

The device 53 may have a round (e.g., circular, elliptical, or ovoid)cross section. In some embodiments, the device 53 includes filaments 59a having a substantially rectangular or flat cross section (e.g.,embodiments in which the device 53 comprises ribbons or uncut portionsof a metallic tube or sheet). In some embodiments, the device 53includes filaments 59 a having a substantially round (e.g., circular,elliptical, ovoid) cross section. The filaments 59 a may be coupled atthe proximal end of the device 53, at the distal end of the device 53,or at both the proximal and distal ends. In some embodiments, thefilaments 59 a are configured to form a mesh, such as a criss-cross orbraided mesh. To form the mesh-like configuration, the filaments 59 amay be attached, welded, glued, adhered, mechanically crimped,mechanically swaged, braided, woven, physical vapor deposited, chemicalvapor deposited, combinations thereof, or the like. In some embodiments,a tube or sheet of desired material may be cut, such as laser cut ormechanically-cut, to form filaments 59 a arranged in a particularconfiguration. Other filament mesh patterns of the device 53 are alsopossible, such as those described below with respect to FIGS. 6A-6L.

In some embodiments, the first section 55 may extend longitudinally fromone side of the protruding section 57. In other embodiments, however,the first section 55 may longitudinally extend from both sides of theprotruding section 57, such that the protruding section 57 is interposedbetween the ends of the first section 55. In certain embodiments, thefirst section 55 may be configured to anchor the device 53 within apatient's vasculature. For example, when the device 53 is placed at abifurcation, the first section 55 may anchor the device 53 in anafferent vessel (e.g., as generally shown in FIGS. 4A and 4B). In otherembodiments, the first section 55 may also or alternatively anchor thedevice 53 in an efferent vessel. In yet other embodiments, the firstsection 55 may anchor the device 53 in a combination of afferent andefferent vessels.

In one or more embodiments, the first section 55 may longitudinallyextend from both sides of the protruding section 57, but may only anchoron one side of the protruding section 57 (e.g., in either the afferentor efferent vessels). As can be appreciated, the first section 55longitudinally extending from both sides of the protruding section 57may ensure that the protruding section 57 remains properly positionedand anchored at the treatment site. The first section 55 may alsofacilitate delivery, positioning, retrieval, and/or repositioning of thedevice 53. The first section 55 may be flexible and yet have enoughradial force to anchor or maintain the position of the device 53 at abifurcation after deployment such that it inhibits or preventsundesirable longitudinal migration of the device 53.

FIG. 1A depicts the device 53 in its expanded configuration and having avariable transverse dimension along its longitudinal axis 61.Specifically, the first section 55 may exhibit a first transversedimension and the protruding section 57 may exhibit a second, largertransverse dimension. As illustrated, the second or protruding section57 bulges or otherwise protrudes radially outward from the first section55, thereby achieving the second transverse dimension. The respectivetransverse dimensions may correspond to the overall width or diameter ofthe device 53 over the respective sections 55, 57 at a given point alongthe longitudinal axis 61.

The device 53 may assume its compressed configuration while in acatheter or other type of elongate delivery device. Upon deployment fromthe catheter, the device 53 may be configured to automatically expandfrom the compressed configuration to its expanded configuration. Theprotruding section 57 may be configured to expand beyond the expandedconfiguration of the device 53 to a “further expanded configuration,”thereby generating or otherwise providing the bulging area in the device53. Accordingly, the device 53 may exhibit a non-uniform cross-sectionaldimension is its expanded or relaxed state. In at least one embodiment,the protruding section 57 may be adapted to expand from the compressedconfiguration to the further expanded configuration without the device53 first transitioning through the expanded configuration.

The protruding section 57 may be made of the same material and patternas the first portion 52, but may be shape-set or otherwise configured tobulge radially outward and generate an increased cross-sectionaldimension or diameter as compared with the other portions of the device53. In some embodiments, the protruding section 57 may bulge radiallyoutward along a portion of its circumference (e.g., along half of thecircumference, along a third of the circumference, etc.). For example,in its fully expanded configuration, the device 53 may be substantiallyco-cylindrical with the first section 55 along one angular portion ofthe circumference of the protruding section 57 and non-co-cylidrical(e.g., due to the bulging of the protruding section 57) along anotherangular portion of the circumference. In other embodiments, theprotruding section 57 may bulge radially outward about the entirecircumference thereof.

In some embodiments, the protruding section 57 may bulge radiallyoutward in a direction generally perpendicular to the longitudinal axis61 of the device 53. In other embodiments, the protruding section 57 maybulge radially outward in a direction other than generally perpendicularto the longitudinal axis 61. In some embodiments, the protruding section57 may be formed of a different pattern and/or material than the firstsection 55. The diameter or circumference of the protruding section 57may increase along an axial length of the protruding section 57 and thendecrease along the remainder of the axial length of the protrudingsection 57.

FIG. 1B illustrates an enlarged view of the protruding section 57. Thebulging or distended portion of the protruding section 57 may resemblean ellipsoid protruding from the device 53. Other shapes are alsopossible such as, but not limited to, a pyramid, a prism, a sphere, acone, a toroid, combinations thereof, and the like, without departingfrom the scope of the disclosure.

In some embodiments, the protruding section 57 may be deployed withinthe patient's vasculature such that it extends across at least a portionof the neck of an aneurysm, thereby reducing the effective width of theneck. In other embodiments, the protruding section 57 may be configuredto extend across the entire neck of the aneurysm. In one or moreembodiments, the protruding section 57 may extend partially within theaneurysm, and in other embodiments, the protruding section 57 may extendpast the aneurysm and into one or both of the afferent and efferentvessels. In operation, the protruding section 57 may serve as ascaffolding section and may allow for the safe and controlled placementof one or more embolization coils within the fundus of the aneurysm. Insome embodiments, the protruding section 57 allows perfusion to efferentvessels.

The device 53 may include a plurality of perforations or cells 62defined by the mutual engagement of the filaments 59 a. In someembodiments, the cells 62 have a size of about 1 mm×about 1.2 mm. Othercell sizes and relative dimensions, such as cells 62 having equal sidelengths, are also possible. Moreover, other cell shapes, such asquadrilateral, parallelogram, rhombus, rectangle, square, hexagon, etc.,are also possible without departing from the scope of the disclosure.

In certain embodiments, a percentage of at least a portion of theprotruding section 57 formed by the filaments 59 a is greater than about3%. In certain embodiments, a percentage of at least a portion of theprotruding section 57 formed by the filaments 59 a is less than about50%. In certain embodiments, a percentage of at least a portion of theprotruding section 57 covered by the cells 62 is less than about 97%. Incertain embodiments, a percentage of at least a portion of theprotruding section 57 covered by the cells 62 is greater than about 50%.In certain embodiments, a percentage of at least a portion of theprotruding section 57 formed by the filaments 59 a is between about 3%and about 25%. In certain embodiments, a percentage of at least aportion of the protruding section 57 covered by the cells 62 is betweenabout 75% and about 97%. As will be appreciated, however, otherporosities and densities of the protruding section 57 are also possible.In some embodiments, a lower porosity may enable the protruding section57 to provide more scaffolding support for embolic material in theaneurysm.

In one or more embodiments, a portion of the protruding section 57 mayinclude additional filaments 59 b configured to increase filamentdensity and, given the appropriate filament density, may enhance theability of the protruding section 57 to act as a scaffolding thatinhibits the herniation or prolapse of objects (e.g., embolic material,thrombi, etc.) from the neck of the aneurysm. In certain embodiments, atleast a portion of the protruding section 57 is substantially devoid ofa mesh or additional filaments 59 b.

In some embodiments, the additional filaments 59 b may be formedseparately and then attached to the protruding section 57 as a collar ora patch. The additional filaments 59 b may be attached to the protrudingsection 57 by various means such as, but not limited to, being welded,glued, adhered, mechanically crimped, mechanically swaged, braided,physical vapor deposited, chemical vapor deposited, combinationsthereof, or the like. In some embodiments, the additional filaments 59 bmay be formed integrally with the remainder of the device 53, such asbeing cut from the original sheet or tubing.

In some embodiments, a portion of the protruding section 57 may exhibita higher porosity than other adjacent portions of the protruding section57. For example, a first portion of the protruding section 57 may beconfigured to extend at least partially across a neck of an aneurysm,and have a lower porosity as compared to a second portion of theprotruding section 57. With a lower porosity, the first portion may bebetter capable of scaffolding and supporting embolic material in theaneurysm. With a higher porosity, the second portion of the protrudingsection 57 may be configured to increase perfusion therethrough.

In some embodiments, at least a portion of the protruding section 57includes a mesh or cover, such as a polymer covering. In suchembodiments, the cover provides a sufficient density that enables thedevice 53 to act as a scaffolding for embolic material. For example, thecover may have a density greater than about 3% (e.g., about 50%), but itwill be appreciated that other densities or porosities are alsopossible. A higher porosity of at least a portion of the protrudingsection 57 enables the protruding section 57 to allow perfusion toefferent vessels. For example, a first portion of the protruding section57 may be configured to extend at least partially across a neck of ananeurysm and may comprise a cover with a density configured to act as ascaffolding for embolic material. A second portion of the protrudingsection 57, however, may be devoid of a cover, thus enabling theprotruding section 57 to increase perfusion therethrough.

In certain embodiments, a percentage of at least a portion of theprotruding section 57 covered by the filaments 59 a is greater thanabout 25%, but can also be less than about 40%. In certain embodiments,a percentage of at least a portion of the protruding section 57 coveredby the cells 62 is less than about 75%, but can also be greater thanabout 60%. In certain embodiments, a percentage of at least a portion ofthe protruding section 57 covered by the filaments 59 a is between about25% and about 40%, and a percentage of at least a portion of theprotruding section 57 covered by the cells 62 may be between about 60%and about 75%. Other porosities and densities of the protruding section57 are also possible, without departing from the scope of thedisclosure.

Such filament coverage and/or porosity may advantageously enable atleast a portion of the protruding section 57 to divert flow from ananeurysm. Diversion of flow may advantageously allow stagnation of bloodflow in the aneurysm, thereby resulting in thrombosis. The illustrateddevice 53 in FIG. 1A, for example, includes additional filaments 59 bcovering a portion of the protruding section 57, thereby increasingfilament density and enhancing the ability of the protruding section 57to divert flow from an aneurysm. In some embodiments, at least a portionof the protruding section 57 exhibits a higher porosity than otherportions of the protruding section 57 in order to strategically divertflow in certain portions and increase perfusion through other portions.

In some embodiments, the portion of the protruding section 57 thatincludes a mesh or covering, such as a polymer covering, may also beconfigured to cause diversion of flow from an aneurysm. For example, thecover may have a porosity that is less than about 25%, and can range toabout 0% porosity in some applications. Other porosities are alsopossible, however, without departing from the scope of the disclosure.In some embodiments, at least a portion of the protruding section 57 issubstantially devoid of a mesh or covering or additional filaments 59 b.For example, a first portion of the protruding section 57 configured toextend at least partially across a neck of an aneurysm may include acover that exhibits a porosity configured to divert flow. A secondportion of the protruding section 57 may be devoid of the cover in orderto increase perfusion therethrough. In certain embodiments, a higherporosity of at least a portion of the protruding section 57 enables theprotruding section 57 to allow perfusion to efferent vessels. In yetother embodiments, the mesh or covering over the portion of theprotruding section 57 may exhibit a density sufficient to causediversion of flow into the aneurysm.

Referring now to FIGS. 2A-2C, illustrated are elevational views ofalternative embodiments of the vascular device 53, according to one ormore embodiments disclosed. FIG. 2A illustrates the device 53 having aprotruding section 57 that bulges radially outward along a portion ofthe circumference of the device 53 in a generally rounded manner. Thedevice 53 in FIG. 2A may be substantially similar to the device 53described above with reference to FIG. 1A. For example, the protrudingsection 57 bulges radially outward along only a portion of itscircumference (e.g., along half of the circumference, along a third ofthe circumference, etc.), but is otherwise substantially co-cylindricalwith the first portion 55 along the remaining portion of thecircumference. In some embodiments, the protruding section 57 may definea generally symmetric cross-sectional profile, thereby exhibiting amirror image from a middle point on each axial or longitudinal end ofthe protruding section 57. In such an embodiment, the protruding section57 may be configured to bulge radially outward so that the outward-mostpoint or area is located substantially at the center of the protrudingsection 57.

In FIG. 2B, the protruding section 57 may be configured to bulgeradially outward towards a point or a line. As illustrated, theresulting bulge of the protruding section may provide the general shapeof a pyramid or prism, for example, Again, the protruding section 57 mayradially bulge about only a portion of the radial circumference of thedevice 53 or about the entirety thereof, without departing from thescope of the disclosure. In some embodiments, the protruding section 57may be configured to bulge radially outward in a non-uniform manner,such as randomly, towards a series of points, towards a curve,combinations thereof, etc. Other embodiments of protruding sections 57with generally symmetric profiles are also possible (e.g., toroidalbulging).

In at least one embodiment, the protruding section 57 shown in FIG. 2Bhas a generally asymmetric cross-sectional profile, where opposingsections extending from a middle point of the protruding section 57,either axially or longitudinally, are substantially dissimilar. Forexample, the protruding section 57 may bulge outwardly so that theoutward most point or area is located away from a point or line or areaat the true center of the protruding section 57. As another example, theprotruding section 57 may bulge outwardly in a non-uniform manner. Asyet another example, the protruding section 57 may be defined by two ormore bulges or protrusions, where the multiple protrusions are notequidistantly or equally spaced about the middle or center of theprotruding section 57.

Referring to FIG. 2C, the device 53 may be configured such that theprotruding section 57 bulges out radially about the entire circumferenceof the device 53. Such embodiments may allow for convenient positioningat the aneurysm since axial rotational orientation of the device 53 maynot be required. For example, upon deployment at a bifurcation, theprotruding section 57 may be configured to flatten along onelongitudinal side due to contact with the vasculature while the opposinglongitudinal side may extend at least partially into the aneurysm orbifurcation as desired. Flexibility and compliance of the device 53 mayreduce or otherwise minimize damage to the surrounding vasculature.

It will be appreciated that combinations of the various protrudingsections 57 described herein are possible, without departing from thescope of the disclosure. For example, the protruding section 57 may beasymmetrical, symmetrical, bulge towards a line or ring around theentire circumference of the device 53, and/or have a first portion thatbulges towards a line and a second portion that bulges in a generallyrounded or arcuate manner.

Referring now to FIGS. 3A and 3B, illustrated is an example of how theprotruding section 57 of the device 53 may achieve a further expandedconfiguration, according to one or more embodiments. FIG. 3A illustratesthe device 53 upon deployment from a catheter or other delivery tubularor device, in which the first section 55 has expanded from itscompressed configuration to its expanded configuration. At this point,the protruding section 57 may be considered to have expanded from acompressed configuration to an intermediate or semi-expandedconfiguration, but has not yet assumed a further expanded configuration.

FIG. 3B depicts the protruding section 57 in its further expandedconfiguration in which the protruding section 57 bulges or otherwiseprotrudes radially outward from the first section 55. It will beappreciated that the protruding section 57 may be configured to expandfrom its compressed configuration directly to its further expandedconfiguration, without requiring the device 53 to transition between itscompressed and expanded configurations. The device 53 may be configuredto be self-expanding under certain conditions, such as when notrestrained by a catheter, or when coming into contact with an externalstimulus such as heat or a chemical agent. In at least one embodiment,the device 53 may be configured to expand when coming into contact witha warm fluid, such as saline. In embodiments where the device 53 isdeployed from a catheter, the protruding section 57 may be adapted toexpand into its further expanded configuration after being released fromthe catheter, while a portion of the first section 55 is stillcompressed within the catheter. With the portion of the first section 55remaining in the catheter, the device 53 may be able to be resheathed orotherwise retracted back into the catheter for repositioning.

In some embodiments, the density of the filaments 59 b (FIG. 1A) in theprotruding section 57 may be configured such that when the device 53 isin its compressed configuration, or otherwise prior to expanding intoits further expanded configuration, the filaments 59 b may exhibit alower porosity or small pore or cell size. In other words, in thecompressed configuration or antecedent to its further expandedconfiguration, the protruding section 57 may exhibit less porosity thanthe first section 55 (FIG. 1A). However, upon full expansion to thefurther expanded configuration, the density of the filaments 59 b in theprotruding section 57 may be configured such that the porosity or cellsizes of the device 53 along its entire axial length is equal orsubstantially equal. Accordingly, in at least one embodiment, theporosity of the filaments 59 a of the first section 55 and the porosityof the filaments 59 b of the protruding section 57 may be approximatelythe same when the device 53 expands to the further expandedconfiguration. An example of such an embodiment may be generally shownin the cell pattern 661 described below with reference to FIG. 6L.

In some embodiments, in a compressed configuration, the first section 55has a first compressed porosity, a first compressed cell size, and afirst compressed cross-sectional dimension. In the compressedconfiguration the protruding section 57 has a second compressedporosity, a second compressed cell size, and a second compressedcross-sectional dimension.

The first compressed porosity may be greater than the second compressedporosity. The first compressed cell size may be greater than the secondcompressed cell size. The first compressed cross-sectional dimension maybe substantially equal to the second compressed cross-sectionaldimension.

In some embodiments, in an expanded configuration, the first section 55has a first expanded porosity, a first expanded cell size, and a firstexpanded cross-sectional dimension. In the expanded configuration, theprotruding section 57 has a second expanded porosity, a second expandedcell size, and a second expanded cross-sectional dimension.

The first expanded porosity may be substantially equal to the secondexpanded porosity. The first expanded cell size may be substantiallyequal to the second expanded cell size. The first expandedcross-sectional dimension may be less than the second expandedcross-sectional dimension.

In some embodiments, the device 53 may be made of a self-expanding,super elastic, and/or a shape-memory material such as, but not limitedto, nitinol, CoCr alloys, shape memory polymers (e.g., polyglycolicacid, polylactic acid), combinations thereof, or the like. In at leastone embodiment, the first section 55 and the protruding section 57 maybe made of different materials. For example, the first section 55 may bemade of a polymer material while the protruding section 57 may be madeof a metallic material or a different polymer material. Othercombinations of materials are also possible, without departing from thescope of the disclosure.

In some embodiments, the device 53 may be at least partially made from,or at least carry with it, a radiopaque marker or material such asplatinum, platinum-iridium, and/or tantalum. In one embodiment, thefilaments 59 a may be radiopaque markers. In other embodiments, certainsegments or portions of the protruding section 57 may be made of orinclude radiopaque markers in the form of marker coils and/or markerbands. In yet other embodiments, the filaments 59 a and certain segmentsof the protruding section 57 may be made of or otherwise includeradiopaque markers. In yet other embodiments, the filaments 59 a orother structural components of the protruding section 57 may be made ofa radiopaque material.

Referring now to FIGS. 4A and 4B, illustrated is an exemplary method orprocess for treating an aneurysm 10 using the vascular device 53 asgenerally described herein, according to one or more embodiments. Asillustrated, the device 53 may be positioned within a patient'svasculature at a bifurcation 71, such as at a neurovascular bifurcation(e.g., the basilar tip area). The bifurcation 71 may include an afferentvessel 67, two or more efferent vessels 68 a, 68 b, and an aneurysm 10.The first section 55 may be configured or otherwise dimensioned to fitwithin the afferent vessel 67. For example, the diameter of the afferentvessel 67 may range between about 2 mm and about 12 mm, between about 6mm and about 8 mm, less than about 15 mm, or greater than about 1 mm,and the first section 55 may be suitably dimensioned to expand and fitthe afferent vessel 67.

In some embodiments, a portion of the protruding section 57 may extendat least partially across an ostium of one of the efferent vessels, suchas the second efferent vessel 68 b. In such embodiments, at least aportion of the protruding section 57 may have a lower density than otherportions of the protruding section 57 to allow perfusion to the secondefferent vessel 68 b. The device 53 may be configured to reduce theeffective width of the neck of the aneurysm 10. For example, the device53 may be configured to act as a scaffolding that inhibits or otherwiseprevents herniation or prolapse of objects 69 (FIG. 4B), such asembolization coils or thrombi, out of the aneurysm 10.

At least a portion of the protruding section 57 may be dense enough thatsuch objects 69 cannot pass therethrough. In some embodiments, however,the protruding section 57 may be configured to allow the insertion ofembolic material therethrough and into the aneurysm 10. For example,embolic material 69 may be inserted or otherwise delivered into theaneurysm 10 through the cells 62 (FIG. 1A) defined between adjacentfilaments 59 a, 59 b (FIG. 1A) or other structural components of theprotruding section 57.

In some embodiments, a relative amount of the protruding section 57 or aportion thereof occupied by the filaments 59 a, 59 b (FIG. 1A), or otherstructural components of the protruding section 57, is between about 3%and about 25%. In some embodiments, a relative amount of the protrudingsection 57 or a portion thereof occupied by the filaments 59 a, 59 b, orother structural components of the protruding section 57, is betweenabout 3% and about 15%. In some embodiments, a relative amount of theprotruding section 57 or a portion thereof occupied by the filaments 59a, 59 b, or other structural component of the protruding section 57, isat least about 5%.

FIG. 4A depicts the first section 55 as it is anchored in the afferentvessel 67 and the protruding section 57 as it is arranged at thejunction of the bifurcation 71 and across the neck of the aneurysm 10.As illustrated, the first section 55 is in its expanded configurationand the protruding section 57 is in its further expanded configuration.To anchor the first section 55 in the afferent vessel 67, the distal tipof a delivery catheter (not shown), such as microcatheter, is trackedthrough the vasculature to reach the location of the bifurcation 71. Thedevice 53 is deployed out of the distal end of the catheter 60, therebyallowing the device 53 to expand. The protruding section 57 expands andfurther expands at or near the junction of the bifurcation 71 and eitherat least partially inside the aneurysm 10 or across the neck of theaneurysm 10. The first section 55 expands within the afferent vessel 67and thereby anchors the device 53. The protruding section 57 acts asscaffolding to inhibit herniation or prolapse of objects 69 (e.g.,embolic material, thrombi, etc.) from the aneurysm 10 and simultaneouslyallows perfusion to the efferent vessels 68 a,b.

In one or more embodiments, the device 53 is able to be fully retrievedinside the catheter whereupon the position of the catheter can beadjusted and the device 53 can be redeployed at a more desirableposition within the vasculature. In other embodiments, the device 53 maybe retracted into the catheter so as to be repositioned in a new axialrotational position, for example, more proximal or distal to theafferent vessel 67 and/or the efferent vessel(s) 68 a,b, etc.Additionally or alternatively, the device 53 can be fully retrievedinside the catheter and a different catheter or the same catheter with adifferent device having different dimensions (e.g., diameter, length,etc.) or exhibiting different more desirable properties (e.g., betteranchoring, better neck coverage, etc.) can be deployed at a moredesirable position within the vasculature. Once the device 53 isaccurately positioned, the device 53 can be detached from the catheterelectrolytically (e.g., by applying a small current until a proximal tipof the device 53 corrodes away), mechanically (e.g., by a releasemechanism), or chemically (e.g., by dissolving a connecting portion witha biocompatible solvent such as DMSO), thereby permanently placing thedevice 53 at the junction of the bifurcation 71. As will be appreciated,other detachment mechanisms are also possible.

The protruding section 57 includes transition portions on both sides ofthe section 57 that transition to the shape of the remaining shape ofthe device 53. In some embodiments, the transition portions can includea taper from an outer extent of the protruding section 57 down to thesurface of the remaining shape of the device 53 (e.g., the first section55). In some embodiments, a taper on a distal portion of the protrudingsection 57 can be the same as a taper on a proximal portion of theprotruding section 57. In some embodiments, the distal portion can taperat a steeper degree than the proximal portion taper. The difference intaper can skew the protruding portion toward the side having a steeperdegree of taper. In some embodiments, the steeper taper can be used toextend across the aneurysm ostium as the device 53 curves along thebifurcation.

FIG. 4B illustrates a plurality of embolization coils 69 inserted in thefundus of the aneurysm 10. The embolization coils 69 may be a singleembolization coil or other embolic material. The embolization coils 69or other embolic material may be inserted into the fundus before,during, and/or after the device 53 is positioned within the vasculature.In some embodiments, the embolization coils 69 are inserted in thefundus of the aneurysm 10 using the same catheter from which the device53 is deployed.

As described herein, the protruding section 57 may perform a variety offunctions, for example, providing support to the embolic material 69,allowing perfusion to the efferent vessels 68 a,b, reducing theeffective width of the neck of the aneurysm 10, and/or inhibiting theprolapse of objects 69 from the neck of the aneurysm 10. The protrudingsection 57 may be atraumatic and made of flexible materials or otherwiseforming atraumatic shapes in order to inhibit damaging or rupturing theaneurysm 10. In one or more embodiments, the protruding section 57, orportions thereof, may be self-conforming to irregular contours ofaneurysm 10, the neck of the aneurysm 10, or the bifurcation 71.

As illustrated, the protruding section 57 may bulge radially outwardfrom the first section 55 and extend partially within the aneurysm 10 ina generally rounded manner. In use, the protruding section 57 may serveas a scaffolding section that maintains the embolization coils 69 withinthe fundus of the aneurysm 10 or otherwise allows for the safe andcontrolled placement of such embolization coils 69 therein. Theprotruding section 57 may also be configured to allow perfusion to theefferent vessels 68 a,b.

Referring now to FIG. 5, illustrated is another application of theexemplary vascular device 53, according to one or more embodiments. Asillustrated, the device 53 is positioned at a bifurcation 71 having anafferent vessel 67, two or more efferent vessels 68 a, 68 b, and ananeurysm 10. The first section 55 of the device 53 may include aproximal portion 55 a and a distal portion 55 b that anchor the device53 on either or both sides of the bifurcation 71. Accordingly, the firstsection 55 extends longitudinally from both axial ends or sides of theprotruding section 57, which may help to properly position theprotruding section 57. The first section 55 may be flexible and yet haveenough radial force to anchor or maintain the position of the device 53at the bifurcation 71 after deployment, thereby inhibiting or preventinglongitudinal migration of the device 53.

Anchoring the distal portion 55 b in the efferent vessel 68 b may beaccomplished as follows. The distal tip of a delivery catheter (notshown), such as a microcatheter or other delivery device that can betracked through the vasculature, is positioned within the efferentvessel 68 b adjacent the aneurysm 10. The device 53 is then deployed outof the distal end of the catheter, thereby allowing the device 53 toexpand either automatically or as a result of coming into contact withan external stimulus (e.g., temperature or chemical stimuli). The distalportion 55 b expands within the efferent vessel 68 b and may serve toanchor the device 53 therein. As the protruding section 57 exits thecatheter, it may expand to its intermediate expanded configuration andthereafter expand even more to the further expanded configuration.

In its further expanded configuration, the protruding section 57 mayextend within the junction of the bifurcation 71 and at least partiallyacross the neck of the aneurysm 10. The proximal portion 55 a thereafterexits the catheter and correspondingly expands within the afferentvessel 67 and may serve to anchor the device 53 therein also.Accordingly, the distal portion 55 b is anchored in the efferent vessel68 b, the proximal portion 55 a is anchored in the afferent vessel 67,and the protruding section 57 acts as scaffolding to inhibit herniationor prolapse of embolic material 69 from the aneurysm 10 and allowsperfusion to the efferent vessels 68 a, 68 b.

As in prior embodiments, the device 53 can be fully retrieved orotherwise resheathed inside the catheter and the device 53 can beredeployed, for example, at a more desirable or accurate position.Moreover, as also in prior embodiments, final release of the device 53from the catheter may be mechanical, electrolytic, and/or chemical.

Referring now to FIGS. 6A-6L, illustrated are exemplary patterns ofcells defined by the cutting, depositing, meshing and/or weaving one ormore filaments 59 a, 59 b on the first and/or second sections 55, 57,according to one or more embodiments. Specifically, various exemplarycell patterns 66 a, 66 b, 66 c, 66 d, 66 e, 66 f, 66 g, 66 h, 66 i, 66j, 66 k, 661 are illustrated that may be incorporated into the vasculardevice 53 as generally described herein to achieve the desiredfunctionality described above. Alternatively, these cell patterns 66 a-1may be used in other types of stents and/or vascular devices such as,but not limited to, stents having a generally a generally uniformoutside diameter along their length.

FIG. 6A illustrates an exemplary cell pattern 66 a that has an “opencell” design. As illustrated, the cell pattern 66 a may be identifiableby the reverse free-peaks 74 and the forward free-peaks 99. Inoperation, open cell designs generally provide good flexibility and wallapposition, but may be difficult to retrieve, for example due to thepotential of the reverse free-peaks 74 of snagging or catching on thecatheter during retrieval.

FIG. 6B illustrates an exemplary cell pattern 66 b that has a “closedcell” design. As illustrated, the cell pattern 66 b may be identifiableby the lack of any peaks due to contact of all defined cells atcorresponding intersections 101. FIG. 6C illustrates another exemplarycell pattern 66 c that has a “closed cell” design. The cell pattern 66 cmay be identifiable by the lack of reverse free-peaks 103 and forwardfree-peaks 108, which are instead connected by one or more filaments105. As will be appreciated, closed cell designs are generally easy todeliver and to retrieve, but may be stiff and provide poor wallapposition. As a result, some closed cell designs may be prone tokinking rather than bending.

FIGS. 6D-6H illustrate exemplary cell pattern embodiments that are“hybrid” or “combination” designs that include features of open andclosed cell designs. As will be appreciated, a hybrid of open cell andclosed cell designs can advantageously incorporate the advantages ofeach design and simultaneously avoid the potential drawbacks of eachdesign. FIG. 6D illustrates an exemplary cell pattern 66 d that has ahybrid cell design. For example, the cell pattern 66 d may includeforward connected peaks 131, 133, forward free-peaks 132, and reverseconnected peaks 134. As illustrated, the forward peaks 133 may beconnected to the next unit cell. The cell pattern 66 d, however, doesnot include any reverse free-peaks, such as the reverse free peaks 74 ofFIG. 6A.

FIG. 6E illustrates an exemplary cell pattern 66 e that also has ahybrid cell design. Similar to the cell pattern 66 d described abovewith reference to FIG. 6D, the cell pattern 66 e may include forwardconnected peaks 131, 133, forward free-peaks 132, and reverse connectedpeaks 134. As illustrated, the forward peaks 133 may be connected to thenext unit cell, but the cell pattern 66 e does not include any reversefree-peaks, such as the reverse free peaks 74 of FIG. 6A.

FIG. 6F illustrates an exemplary cell pattern 66 f that also has ahybrid cell design. As illustrated, the cell pattern 66 f may includeforward connected peaks 131, forward free-peaks 132, and reverseconnected peaks 134. The cell pattern 66 f may further include valleys135 connected to the next unit cell. The cell pattern 66 f, however,does not include any reverse free-peaks, such as the reverse free peaks74 of FIG. 6A.

FIG. 6G illustrates an exemplary cell pattern 66 g that also has hybridcell design. Similar to the cell pattern 66 f described above withreference to FIG. 6F, the pattern 66 g may include forward connectedpeaks 131, forward free-peaks 132, and reverse connected peaks 134. Asillustrated, the cell pattern 66 g may also include valleys 135connected to the next unit cell, but the cell pattern 66 g does notinclude any reverse free-peaks, such as the reverse free peaks 74 ofFIG. 6A.

FIG. 6H illustrates an exemplary cell pattern 66 h that also has ahybrid cell design. As illustrated, the cell pattern 66 h may includeforward connected peaks 133, forward free-peaks 132, and reverseconnected peaks 134. The forward peaks 133 may be connected to the nextunit cell, and each unit cell may include forward connected peaks 133alternating with forward free-peaks 132. Moreover, the cell pattern 66 hmay further include peaks connected to the next unit cell. The cellpattern 66 h, however, does not include any reverse free-peaks, such asthe reverse free peaks 74 of FIG. 6A.

FIG. 6I illustrates an exemplary cell pattern 66 i that also has ahybrid cell design. As illustrated, the cell pattern 66 i may includeforward connected peaks 133, forward free-peaks 132, and reverseconnected peaks 134. The forward peaks 133 may be connected to the nextunit cell, and each unit cell may include forward connected peaks 133alternating with forward free-peaks 132. The cell pattern 66 i mayfurther include peaks connected to the next unit cell, but the cellpattern 66 i does not include any reverse free-peaks, such as thereverse free peaks 74 of FIG. 6A. In contrast to the cell pattern 66 hof FIG. 6H, the cell pattern 66 i of FIG. 6I has fewer diagonalfilaments (e.g., missing in the indicated area 138), which may provideincreased flexibility and/or wall apposition.

FIG. 6J illustrates an exemplary cell pattern 66 j that also has ahybrid cell design. As illustrated, the cell pattern 66 j may includeforward connected peaks 133, forward free-peaks 132, and reverseconnected peaks 134. The forward connected peaks 133 may be connected tothe next unit cell, and each unit cell may include forward connectedpeaks 133 alternating with forward free-peaks 132. The cell pattern 66 jmay further include peaks connected to the next unit cell, however, thecell pattern 66 j does not include any reverse free-peaks, such as thereverse free peaks 74 of FIG. 6A. In contrast to the cell pattern 66 iof FIG. 6I, the cell pattern 66 j of FIG. 6J may not include one or morestraight filaments 109, which may help the cell pattern 66 i be lessprone to twisting during compaction.

FIG. 6K illustrates an exemplary cell pattern 66 k that also has ahybrid or combination cell design. As illustrated, the cell pattern 66 kmay include a plurality of reverse free peaks 74, a plurality of reverseconnected peaks 134, and a plurality of forward connected peaks 133.Across at least a circumferential portion of the cell pattern 66 k, thereverse free peaks 74 may alternate with the reverse connected peaks134. In some cases, the forward and reverse connected peaks 131, 134 arecoupled with a straight filament 109 configured to enlarge the size ofthe cells and help the cell pattern 66 k be less prone to twistingduring compaction. The cell pattern 66 k, however, may not includeforward free peaks 132, as in cell pattern 66 d described above withreference to FIG. 6D.

Referring briefly to FIG. 7A, with continued reference to FIG. 6K,illustrated is an exemplary vascular remodeling device 53 that employsthe cell pattern 66 k, and is shown as being in its further expandedconfiguration. As illustrated, the device 53 includes a plurality ofreverse free and connected peaks 74, 134 and a plurality of forwardconnected peaks 133, where the reverse free peaks 74 are configured toalternate with the reverse connected peaks 134. Moreover, a plurality ofstraight filaments 109 serve to connect many of the forward and reverseconnected peaks 131, 134 in several areas about the circumference of thedevice 53.

FIG. 6L illustrates an exemplary cell pattern 661 that also has a hybridor combination cell design. As illustrated, the cell pattern 661 mayinclude a plurality of reverse free peaks 74, a plurality of reverseconnected peaks 134, a plurality of forward free peaks 132, and aplurality of forward connected peaks 133. The reverse and forwardconnected peaks 134, 133 may be coupled together at their variouslocations about the circumference of the cell pattern 661. Unlike cellpattern 66 k, however, the cell pattern 661 does not necessarily includeone or more straight filaments 109.

Referring briefly to FIG. 7B, with continued reference FIG. 6L,illustrated is an exemplary vascular remodeling device 53 that employsthe cell pattern 661, and is shown as being in its further expandedconfiguration. As illustrated, the device 53 may be substantiallysimilar to the device 53 shown above in FIG. 2C, where the protrudingsection 57 bulges out radially about the entire circumference of thedevice 53. Specifically, the device 53 shown in FIG. 7B may include aplurality of reverse free and connected peaks 74, 134 and a plurality offorward free and connected peaks 132, 133. The reverse and forwardconnected peaks 134, 133 may be coupled together at various locationsabout the circumference of the device 53, as indicated.

Combinations of the features of the various cell patterns illustrated inFIGS. 6A-6L may be selected based on desired structural properties ofthe first section 55 and the protruding section 57 (FIG. 1A). Forexample, the first section 55 may include an open cell design and theprotruding section 57 may include a closed cell design, or vice versa.In other embodiments, the first section 55 may include an open or aclosed cell design and the protruding section 57 may include a hybridcell design, or vice versa. In other embodiments, both the first andprotruding sections 55, 57, may include an open or a closed cell design.In yet other embodiments, both the first and protruding sections 55, 57may include a hybrid cell design.

Embodiments of the device 53 in which the first section 55 extendslongitudinally from the protruding section 57 on one side and isconfigured to anchor in an afferent vessel may comprise a hybrid celldesign in at least a portion of the first section 55. A hybrid celldesign may advantageously provide good flexibility and/or good wallapposition of the first section 55 in the afferent vessel and/or havegood retrieval characteristics due to the lack of reverse free-peaks.For example, the protruding section 57 may expand in the junction (e.g.,a bifurcation having an aneurysm) and the first section 55 may expand inthe afferent vessel, after which at least a portion of the first section55 may be at least partially retrieved back into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inthe first section 55 and a hybrid cell design in the protruding section57. A hybrid cell design in the protruding section 57 may advantageouslyprovide good retrieval characteristics. For example, the protrudingsection 57 may expand in the junction (e.g., a bifurcation having ananeurysm) and the first section 55 may expand in the afferent vessel,after which the first section 55 and at least a portion of theprotruding section 57 may be at least partially retrieved back into thecatheter.

In some embodiments, the device 53 may include a hybrid cell design inthe first section 55 and a closed cell design in the protruding section57. A closed cell design in the protruding section 57 may advantageouslyprovide good retrieval characteristics and may lack disadvantages thatmay be associated with closed cell designs. For example, the protrudingsection 57 may expand in the junction (e.g., a bifurcation having ananeurysm), where flexibility and wall apposition may be less importantand/or where rigidity may be advantageous, and the first section 55 mayexpand in the afferent vessel, after which the first section and atleast a portion of the protruding section may be at least partiallyretrieved back into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inthe first section 55 and an open cell design in the protruding section57. An open cell design in the protruding section 57 may advantageouslyprovide good flexibility. For example, the protruding section 57 mayexpand in the junction (e.g., a bifurcation having an aneurysm) and/orat least partially within an aneurysm, during which the flexibleprotruding section 57 may better conform to the shape of the junctionand/or reduce the likelihood of puncturing the aneurysm. Moreover, thefirst section 55 may expand in the afferent vessel after which at leasta portion of the first section 55 may be at least partially retrievedback into the catheter.

As will be appreciated, combinations of cell designs within each of thefirst section 55 and the protruding section 57 are also possible,without departing from the scope of the disclosure. For example, aproximal portion of the first section 55 may have a hybrid cell designand a distal portion of the first section 55 may have an open celldesign. In other embodiments, a first portion of the protruding section57 may be configured to allow perfusion to branch vessels and may have ahybrid cell design, and a second portion of the protruding section 57may be configured to act as a scaffolding and may have a closed celldesign.

Embodiments of the device 53 in which the first section 55 extendslongitudinally past the protruding section 57 on one side and isconfigured to anchor in an efferent vessel may include a hybrid celldesign in at least a portion of the protruding section 57 toadvantageously exhibit good retrieval characteristics (e.g., due to thelack of reverse free-peaks). For example, the first section 55 mayexpand in the efferent vessel and the protruding section 57 may expandin the junction (e.g., a bifurcation having an aneurysm), after which atleast a portion of the protruding section 57 may be at least partiallyretrieved back into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inthe protruding section 57 and a hybrid cell design in the first section55. A hybrid cell design in the first section 55 may advantageouslyprovide good flexibility and/or wall apposition of the first section 55in the efferent vessel and/or good retrieval characteristics. Forexample, the first section 55 may expand in the efferent vessel and theprotruding section 57 may expand in the junction (e.g., a bifurcationhaving an aneurysm), after which the protruding section 57 and at leasta portion of the first section 55 may be at least partially retrievedback into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inthe first section 55 and a closed cell design in the protruding section57. A closed cell design in the first section 55 may advantageouslyprovide good retrieval characteristics. For example, the first section55 may expand in the efferent vessel and the protruding section 57 mayexpand in the junction (e.g., a bifurcation having an aneurysm), afterwhich the protruding section 57 and at least a portion of the firstsection 55 may be at least partially retrieved back into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inthe protruding section 57 and an open cell design in the first section55. An open cell design in the first section 55 may advantageouslyprovide good flexibility and/or wall apposition. For example, the firstsection 55 may anchor in the efferent vessel and the protruding section57 may expand in the junction (e.g., a bifurcation having an aneurysm),after which the portion of the protruding section 57 may be at leastpartially retrieved back into the catheter.

As will be appreciated, various combinations of cell designs within eachof the protruding section 57 and the first section 55 are also possible,without departing from the scope of the disclosure. For example, aproximal portion of the protruding section 57 may have a hybrid celldesign and a distal portion of the protruding section 57 may have anopen cell design. As another example, a first portion of the protrudingsection 57 configured to allow perfusion to branch vessels may have ahybrid cell design and a second portion of the protruding section 57configured to act as a scaffolding may have a closed cell design.

In embodiments of the device 53 in which the first section 55 extendslongitudinally from both sides of the protruding section 57 (e.g., theproximal portion 55 a and the distal portion 55 b shown in FIG. 5), andis configured to anchor in at least one of an afferent vessel and anefferent vessel, at least a portion of the proximal portion 55 a mayinclude a hybrid cell design. The hybrid cell design may advantageouslyprovide good flexibility and/or wall apposition of the first section 55in the afferent vessel and/or have good retrieval characteristics (e.g.,due to the lack of reverse free-peaks). For example, the distal portion55 b may expand in the efferent vessel, the protruding section 57 mayexpand in the junction, and the proximal first section may expand in theafferent vessel, after which at least a portion of the proximal portion55 a may be at least partially retrieved back into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inthe proximal portion 55 a and a hybrid cell design in the protrudingsection 57. The hybrid cell design in the protruding section 57 mayadvantageously provide good retrieval characteristics. For example, thedistal portion 55 b may expand in the efferent vessel, the protrudingsection 57 may expand in the junction, and the proximal portion 55 a mayexpand in the afferent vessel, after which the proximal portion 55 a andat least a portion of the protruding section 57 may be at leastpartially retrieved back into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inthe first section 55 (e.g., the proximal and distal portions 52 a,b) andin the protruding section 57. For example, in embodiments of the device53 in which the first section 55 anchors in the afferent and efferentvessels, the hybrid cell design in the distal portion 55 b mayadvantageously provide good flexibility and/or good wall apposition inthe distal portion 55 b and/or have good retrieval characteristics(e.g., due to the lack of reverse free-peaks). Moreover, the distalportion 55 b may anchor in the efferent vessel, the protruding section57 may expand in the junction, and the proximal portion 55 a may anchorin the afferent vessel, after which the proximal portion 55 a, theprotruding section 57, and at least a portion of the distal portion 55 bmay be at least partially retrieved back into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inat least a portion of the proximal portion 55 a and a closed cell designin the protruding section 57. A closed cell design in the protrudingsection 57 may advantageously provide good retrieval characteristics andmay lack the disadvantages that may be associated with closed celldesigns. The distal portion 55 b may expand in the efferent vessel, theprotruding section 57 may expand in the junction where flexibility andwall apposition may be less important and/or where rigidity may beadvantageous, and the proximal portion 55 a may expand in the afferentvessel. During delivery, the proximal portion 55 a and at least aportion of the protruding section 57 may be at least partially retrievedback into the catheter for repositioning. In other embodiments, theproximal portion 55 a, the protruding section 57, and at least a portionof the distal portion 55 b may be at least partially retrieved back intothe catheter.

In some embodiments, the device 53 may include a hybrid cell design inthe proximal portion 55 a and a closed cell design in at least a portionof the distal portion 55 b. The closed cell design in the distal portion55 b may advantageously provide good retrieval characteristics. Inembodiments in which the distal portion 55 b does not anchor in anefferent vessel, a closed cell design in the distal portion 55 b mayadvantageously lack disadvantages that may be associated with closedcell designs. For example, the distal portion 55 b may expand in theefferent vessel without contacting or conforming to the walls of theefferent vessels but still providing a fluid flow path from the afferentvessel to the efferent vessel, the protruding section 57 may expand inthe junction, and the proximal portion 55 a may anchor in the afferentvessel. After full or partial expansion of the device 53, the proximalportion 55 a, the protruding section 57, and at least a portion of thedistal portion 55 b may be at least partially retrieved back into thecatheter for repositioning.

In some embodiments, the device 53 may include a hybrid cell design inat least a portion of the distal portion 55 b and a closed cell designin at least a portion of the proximal portion 55 a. The closed celldesign in the proximal portion 55 a may advantageously provide goodretrieval characteristics. In embodiments in which the proximal portion55 a does not anchor in the afferent vessel, a closed cell design in theproximal portion 55 a may advantageously lack disadvantages that may beassociated with closed cell designs. A hybrid cell design in the distalportion 55 b may advantageously provide good flexibility and/or goodwall apposition in the distal portion 55 b and/or have good retrievalcharacteristics. For example, the proximal portion 55 a may expand inthe afferent vessel without contacting or conforming to the walls of theafferent vessel but still providing a fluid flow path from the afferentvessel to the efferent vessels, the protruding section 57 may expand inthe junction, and the distal portion 55 b may anchor in the efferentvessel. After expansion of the device 53, the proximal portion 55 a, theprotruding section 57, and at least a portion of the distal portion 55 bmay be at least partially retrieved back into the catheter.

In some embodiments, the device 53 may include a hybrid cell design inat least a portion of the proximal portion 55 a and an open cell designin the protruding section 57. An open cell design in the protrudingsection 57 may advantageously provide good flexibility. For example, thedistal portion 55 b may expand in the efferent vessel, the protrudingsection 57 may expand in the junction and/or at least partially withinan aneurysm, during which the flexible protruding section 57 may betterconform to the shape of the junction and/or reduce the likelihood ofpuncturing the aneurysm, and the proximal portion 55 a may expand in theafferent vessel. After partial or full deployment of the device 53, atleast a portion of the proximal portion 55 a may be at least partiallyretrieved back into the catheter.

In some embodiments, the proximal portion 55 a comprises a hybrid celldesign and at least a portion of the distal portion 55 b comprises anopen cell design. An open cell design in the distal portion 55 b mayadvantageously provide good flexibility and/or wall apposition. Theseadvantages may be beneficial in embodiments in which the distal portion55 b anchors in an efferent vessel. For example, the proximal portion 55a may anchor in the afferent vessel, the protruding section 57 mayexpand in the junction, and the distal portion 55 b may anchor in theefferent vessel, after which the proximal portion 55 a, the protrudingsection 57, and at least a portion of the distal portion 55 b may be atleast partially retrieved back into the catheter.

It will be appreciated that combinations of cell designs within each ofthe protruding section 54, the proximal portion 55 a, and the distalportion 55 b are also possible, without departing from the scope of thedisclosure. For example, a more proximal section of the proximal portion55 a may have a hybrid cell design and a distal section of the proximalportion 55 a may have an open cell design. As another example, a firstportion of the protruding section 57 configured to allow perfusion tobranch vessels may have a hybrid cell design and a second portion of theprotruding section 57 configured to act as a scaffolding may have aclosed cell design.

Referring again to FIGS. 6B, 6D, 6F, and 6K, the illustrated cellpatterns 66 b, 66 d, 66 f, 66 k, respectively, each have one taperedsection 71. The illustrated cell patterns 66 a, 66 c, 66 e, 66 g, 66 h,66 i, 66 j in FIGS. 6A, 6C, 6E, 6G, 6H, 6I, and 6J, respectively,however, have two tapered sections 71. The tapered sections 71 may allowthe device 53 or portions thereof (e.g., the first section 55, theprotruding section 57, etc.) to be retrieved back into a catheter forrepositioning. For example, if the device 53 is being pulled into acatheter, the tapered portions 71 may radially compress the firstsection 55, thereby facilitating easier retrieval back into thecatheter.

A single tapered section 71 may advantageously have only one detachmentzone or location and be easy to release, while a plurality of taperedsections 71 may include a detachment zone or location proximal to eachtapered section 71 and may be more difficult to release. In one or moreembodiments, the plurality of tapered sections 71 may exhibit a shortertaper length but simultaneously provide a longer effective length.Moreover, the single tapered section 71 may exhibit a longer taperlength but and a shorter effective length, thereby facilitating lessanchoring effect in the vasculature.

In some embodiments, the plurality of tapered sections 71 may be moresymmetrical and provide more uniform wall apposition than embodiments ofthe device 53 having only a single tapered section 71. Moreover, theplurality of tapered sections 71 may exhibit less tension on thevasculature, which may result from a single long tapered area applyingforce to a single side of the vasculature. The effective length of thedevice 53 may be based on the intended anatomy. For example, longerlengths may be appropriate for more vessel wall apposition, whileshorter lengths may be appropriate for traversing more tortuous anatomy.

Referring again to FIGS. 6C, 6F, and 6G, the illustrated cell patterns66 c, 66 f, 66 g, respectively, may include a plurality of s-shapedfilaments 105 configured to connect certain forward peaks and reversepeaks. The cell patterns 66 d, 66 e, 66 j, 66 k of FIGS. 6D, 6E, 6J, and6K, respectively, further include straight filaments 109 configured toconnect certain forward peaks and reverse peaks. The cell patterns 66 h,66 i of FIGS. 6H and 6I, respectively, further illustrate c-shapedfilaments 110 configured to connect certain forward peaks and reversepeaks. As will be appreciated, the curved connection filaments 105, 110exhibiting an s-shape or c-shape curvature may be more flexible than thestraight filaments 109, but may be prone to twisting during compaction.The straight filaments 109, on the other hand, may be easier to compressbut less flexible than the curved connection filaments 105, 110.Accordingly, the straight filaments 109 may be more acceptable forhybrid cell designs already having suitable flexibility.

FIGS. 6D, 6E, and 6L illustrate cell patterns 66 d, 66 e, 661,respectively, having tip-to-tip connections between forward and reversepeaks. Such a configuration may provide a smaller compaction profile forthe device 53. FIGS. 6F, 6G, 6H, and 6I illustrate cell patterns 66 f,66 g, 66 h, 66 i having at least partially offset tip-to-tip connectionsbetween forward and reverse peaks. Such a configuration may provideincreased flexibility and/or may increase vessel conformance.

FIGS. 6D, 6E, 6H, 6I, and 6J illustrate cell patterns 66 d, 66 e, 66 h,66 i, 66 j, respectively, having tip-to-tip connections between forwardand reverse peaks of unit cells. Such a configuration may provide aneasier compaction profile. FIGS. 6F and 6G illustrate cell patterns 66f, 66 g, respectively, having valley-to-tip connections between forwardand reverse peaks of unit cells. Such a configuration may provideincreased flexibility for the device 53.

It will be appreciated that the various cell patterns described hereincan be repeated (e.g., repetition of rows of unit cells), adjusted(e.g., different angles, different lengths, different thicknesses,etc.), and/or combined (e.g., permutations of any of the featuresdisclosed herein) based on the desired properties of the device 53 orother vascular devices in which the patterns(s) are employed. In someembodiments, radiopaque markers may be integrated into a portion (e.g.,the distal peaks of the forward free-peaks, around the filaments, etc.)of the device 53 so that a user (e.g., a physician) is able to activelymonitor placement of the device 53. It will further be appreciated thatboth the first section 55 and the protruding section 57 may be formed byany of the patterns described herein, or any combination thereof. Duringthe manufacturing or forming process for the device 53, the section ofthe device 53 that is to become the protruding section 57 may undergoheat treatment configured to shape set the pregnant portion 54 into thebulged configurations as generally described herein.

In one or more embodiments, FIGS. 6A-6L illustrate exemplary embodimentsof at least a portion of the vascular device 53 at a stage of anexemplary manufacturing process that includes cutting and shaping ametallic sheet. A laser or electrochemical etching may cut out portionsof the sheet, leaving a plurality of filaments, such as the filaments 59a, 59 b described above with reference to FIG. 1A. In some embodiments,the first section 55 and the protruding section 57 may be integrallyformed from the metallic sheet and otherwise not cut away from eachother or separated. In embodiments in which both sections of the deviceare integrally fabricated by being cut from the same tube or sheet, thedevice may be characterized as a single-piece construction. The cut maybe defined by features such as a thickness of the filaments, number offilaments, configuration and/or pattern of the filaments, etc.

The physical properties of the device 53 may be uniform throughout thedevice 53, or may vary depending on location or application. Forexample, filaments in a portion of the protruding section 57 may bethicker or higher in quantity than filaments in other portions of thedevice 53. Dimensions may be selected, for example, to accommodatecertain vasculature, for flexibility, for wall conformance, etc.

After cutting or chemical etching, the sheet may be reshaped, such asinto the shape of a tube or tubular, and the device 53 may be heattreated to shape set the first section 55 and the protruding section 57.The shape setting process may include successively shaping the sheetusing an appropriate tooling (e.g., a mandrel) to stretch and confinethe cut sheet into a new shape during the heat treatment. At the end ofeach heat treatment step, the cut sheet assumes the shape to which itwas confined during the heat treatment process.

After shape setting the device 53, the protruding section 57 may beshaped further such that it is capable of transitioning into the furtherexpanded configuration. For example, the device 53 may be further heattreated to impart further shape setting (e.g., extruding the sheet ortube or otherwise causing it to bulge outwardly) to at least theprotruding section 57. The final shape and size of the protrudingsection 57 (e.g., the desired shape of the further expandedconfiguration) may obtained by repeating this process several times.

In order to obtain the final tubular shape of the device 53, oppositesides of the sheet may be required to be joined at the edges. In someembodiments, the edges may be welded, glued, adhered, mechanicallycrimped, mechanically swaged, braided, physical vapor deposited,chemical vapor deposited, or otherwise joined together to form acomplete tubular profile. The various vascular implant devices describedherein may also be formed using a cut metallic tube that is reshapedafter being cut, although it will be appreciated that the properties ofthe initial tube and the pattern of the cut may be different.

In one or more embodiments, the first section 55 and the protrudingsection 57 may be integrally formed from the metallic tube or sheet andnot cut away from each other. In embodiments in which both sections 55,57 of the device 53 are integrally fabricated by being cut from the sametube or sheet, the device 53 may be characterized as a single-piece ormonolithic construction. Single-piece construction may allow for easiermanufacturing.

In other embodiments, however, some or all of the first section 55and/or the protruding section 57 may be formed separately, and theseparately formed portions may be coupled together by being welded,glued, adhered, mechanically crimped, mechanically swaged, braided,physical vapor deposited, chemical vapor deposited, combinationsthereof, or the like. For example, the first separately formed portionmay be cut from a tube or sheet and then be attached (e.g., welded,glued, adhered, mechanically crimped, mechanically swaged, braided,physical vapor deposited, chemical vapor deposited, etc.) to a pregnantportion cut from a separate tube of sheet. In such embodiments, theprotruding section 57 may be made of a different material than the firstsection 55. In one or more embodiments, for example, the protrudingsection 57 may be made of platinum, platinum-iridium, or a polymer andthe first section 55 may be made of nitinol or a CoCr alloy. Othercombinations of materials are also possible, without departing from thescope of the disclosure. Separate or multi-piece construction may allowfor independent selection of materials that are suited for the intendeduse.

Certain devices described herein may be advantageously used to treataneurysms having a neck ratio (a ratio of fundus width to neck width)greater than about 2 to 1 and/or a neck width greater than about 4 mm.In treatment of such aneurysms, embolization coils may be prone toherniating into parent vessels because the size and/or shape of theaneurysm is not conducive to maintaining the coils in their insertedlocus. In certain such embodiments, embolization coils are inserted inthe fundus of the aneurysm after positioning a vascular device so thatthe embolization coils do not have an opportunity to herniate. It willbe appreciated that certain devices described herein may also be used totreat aneurysms having a neck ratio less than about 2 to 1 and/or a neckwidth less than about 4 mm. In certain such embodiments, embolizationcoils may be inserted in the fundus of the aneurysm before positioning avascular device.

Certain devices described herein may be advantageously used to treataneurysms located off the efferent vessels or side branches of thebifurcation (e.g., having a neck substantially open to an efferentvessel). Devices traditionally used in treating aneurysms may havedifficulty navigating to such locations and remaining anchored andstabilized at such locations. The embodiments of the device 53 disclosedherein, however, may overcome the difficulties encountered by thosetraditional devices. For example, the first section 55 may provideanchoring combined with the protruding section 57 which may providescaffolding or reducing the effective neck size of the aneurysm.

“Occluding device” and “stent” are sometimes used hereininterchangeably. In some embodiments, “cell” and “pore” as used hereinare used interchangeably. In some embodiments, porosity refers to avalue inversely proportional to lattice density.

The apparatus and methods discussed herein are not limited to thedeployment and use of an occluding device within any particular vessels,but may include any number of different types of vessels. For example,in some aspects, vessels may include arteries or veins. In some aspects,the vessels may be suprathoracic vessels (e.g., vessels in the neck orabove), intrathoracic vessels (e.g., vessels in the thorax), subthoracicvessels (e.g., vessels in the abdominal area or below), lateral thoracicvessels (e.g., vessels to the sides of the thorax such as vessels in theshoulder area and beyond), or other types of vessels and/or branchesthereof.

In some aspects, the suprathoracic vessels may comprise at least one ofintracranial vessels, cerebral arteries, and/or any branches thereof.For example, the suprathoracic vessels may comprise at least one of acommon carotid artery, an internal carotid artery, an external carotidartery, a middle meningeal artery, superficial temporal arteries, anoccipital artery, a lacrimal (ophthalmic) artery, an accessory meningealartery, an anterior ethmoidal artery, a posterior ethmoidal artery, amaxillary artery, a posterior auricular artery, an ascending pharyngealartery, a vertebral artery, a left middle meningeal artery, a posteriorcerebral artery, a superior cerebellar artery, a basilar artery, a leftinternal acoustic (labyrinthine) artery, an anterior inferior cerebellarartery, a left ascending pharyngeal artery, a posterior inferiorcerebellar artery, a deep cervical artery, a highest intercostal artery,a costocervical trunk, a subclavian artery, a middle cerebral artery, ananterior cerebral artery, an anterior communicating artery, anophthalmic artery, a posterior communicating artery, a facial artery, alingual artery, a superior laryngeal artery, a superior thyroid artery,an ascending cervical artery, an inferior thyroid artery, athyrocervical trunk, an internal thoracic artery, and/or any branchesthereof. The suprathoracic vessels may also comprise at least one of amedial orbitofrontal artery, a recurrent artery (of Heubner), medial andlateral lenticulostriate arteries, a lateral orbitofrontal artery, anascending frontal (candelabra) artery, an anterior choroidal artery,pontine arteries, an internal acoustic (labyrinthine) artery, ananterior spinal artery, a posterior spinal artery, a posterior medialchoroidal artery, a posterior lateral choroidal artery, and/or branchesthereof. The suprathoracic vessels may also comprise at least one ofperforating arteries, a hypothalamic artery, lenticulostriate arteries,a superior hypophyseal artery, an inferior hypophyseal artery, ananterior thalamostriate artery, a posterior thalamostriate artery,and/or branches thereof. The suprathoracic vessels may also comprise atleast one of a precentral (pre-Rolandic) and central (Rolandic)arteries, anterior and posterior parietal arteries, an angular artery,temporal arteries (anterior, middle and posterior), a paracentralartery, a pericallosal artery, a callosomarginal artery, a frontopolarartery, a precuneal artery, a parietooccipital artery, a calcarineartery, an inferior vermian artery, and/or branches thereof.

In some aspects, the suprathoracic vessels may also comprise at leastone of diploic veins, an emissary vein, a cerebral vein, a middlemeningeal vein, superficial temporal veins, a frontal diploic vein, ananterior temporal diploic vein, a parietal emissary vein, a posteriortemporal diploic vein, an occipital emissary vein, an occipital diploicvein, a mastoid emissary vein, a superior cerebral vein, efferenthypophyseal veins, infundibulum (pituitary stalk) and long hypophysealportal veins, and/or branches thereof.

The intrathoracic vessels may comprise the aorta or branches thereof.For example, the intrathoracic vessels may comprise at least one of anascending aorta, a descending aorta, an arch of the aorta, and/orbranches thereof. The descending aorta may comprise at least one of athoracic aorta, an abdominal aorta, and/or any branches thereof. Theintrathoracic vessels may also comprise at least one of a subclavianartery, an internal thoracic artery, a pericardiacophrenic artery, aright pulmonary artery, a right coronary artery, a brachiocephalictrunk, a pulmonary trunk, a left pulmonary artery, an anteriorinterventricular artery, and/or branches thereof. The intrathoracicvessels may also comprise at least one of an inferior thyroid artery, athyrocervical trunk, a vertebral artery, a right bronchial artery, asuperior left bronchial artery, an inferior left bronchial artery,aortic esophageal arteries, and/or branches thereof.

In some aspects, the intrathoracic vessels may also comprise at leastone of a right internal jugular vein, a right brachiocephalic vein, asubclavian vein, an internal thoracic vein, a pericardiacophrenic vein,a superior vena cava, a right superior pulmonary vein, a leftbrachiocephalic vein, a left internal jugular vein, a left superiorpulmonary vein, an inferior thyroid vein, an external jugular vein, avertebral vein, a right highest intercostal vein, a 6th rightintercostal vein, an azygos vein, an inferior vena cava, a left highestintercostal vein, an accessory hemiazygos vein, a hemiazygos vein,and/or branches thereof.

In some aspects, the subthoracic vessels may comprise at least one ofrenal arteries, inferior phrenic arteries, a celiac trunk with commonhepatic, left gastric and splenic arteries, superior suprarenalarteries, a middle suprarenal artery, an inferior suprarenal artery, aright renal artery, a subcostal artery, 1st to 4th right lumbararteries, common iliac arteries, an iliolumbar artery, an internal iliacartery, lateral sacral arteries, an external iliac artery, a testicular(ovarian) artery, an ascending branch of deep circumclex iliac artery, asuperficial circumflex iliac artery, an inferior epigastric artery, asuperficial epigastric artery, a femoral artery, a ductus deferens andtesticular artery, a superficial external pudendal artery, a deepexternal pudendal artery, and/or branches thereof. The subthoracicvessels may also comprise at least one of a superior mesenteric artery,a left renal artery, an abdominal aorta, an inferior mesenteric artery,colic arteries, sigmoid arteries, a superior rectal artery, 5th lumbararteries, a middle sacral artery, a superior gluteal artery, umbilicaland superior vesical arteries, an obturator artery, an inferior vesicaland artery to ductus deferens, a middle rectal artery, an internalpudendal artery, an inferior gluteal artery, a cremasteric, pubic(obturator anastomotic) branches of inferior epigastric artery, a leftcolic artery, rectal arteries, and/or branches thereof.

In some aspects, the lateral thoracic vessels may comprise at least oneof humeral arteries, a transverse cervical artery, a suprascapularartery, a dorsal scapular artery, and/or branches thereof. The lateralthoracic vessels may also comprise at least one of an anteriorcircumflex humeral artery, a posterior circumflex humeral artery, asubscapular artery, a circumflex scapular artery, a brachial artery, athoracodorsal artery, a lateral thoracic artery, an inferior thyroidartery, a thyrocervical trunk, a subclavian artery, a superior thoracicartery, a thoracoacromial artery, and/or branches thereof.

In some embodiments, a catheter, such as that described in U.S. patentapplication Ser. No. 12/731,110, which was filed on Mar. 24, 2010 andwhich is incorporated herein by reference in its entirety, can be usedto deliver an occluding device delivery system. The delivery system caninclude an expandable occluding device (e.g., stent) configured to beplaced across an aneurysm that is delivered through the distal portionof the catheter, out a distal tip, and into the vasculature adjacent ananeurysm in, for example, the middle cerebral artery. A proximal portionof the catheter can remain partially or entirely within a guidingcatheter during delivery, and an intermediate portion, taper portion,and distal portion of the catheter can extend distally of the guidingcatheter. The occluding device can be released at the target locationand can be used to occlude blood flow into the aneurysm. The cathetercan be used to reach target locations (e.g., aneurysms) locatedelsewhere in the body as well, include but not limited to otherarteries, branches, and blood vessels such as those described above.

In some embodiments, a method of implantation and monitoring can beused, for example, with the deployment systems described above. Themethod can include implanting an occluding device within the vasculatureof a patient such that the device extends, within and along a vessel,past an aneurysm. Example occluding devices, deployment devices,microcatheters for delivery of occluding devices, and deployment methodsare described in U.S. Provisional Application No. 60/574,429, filed onMay 25, 2004; U.S. patent application Ser. No. 11/136,395 (U.S. PatentApplication Publication No. 2005/0267568), filed on May 25, 2005; U.S.patent application Ser. No. 11/420,025 (U.S. Patent ApplicationPublication No. 2006/0206200), filed on May 24, 2006; U.S. patentapplication Ser. No. 11/420,027 (U.S. Patent Application Publication No.2006/0206201), filed on May 24, 2006; U.S. patent application Ser. No.11/136,398 (U.S. Patent Application Publication No. 2006/0271149), filedon May 25, 2005; U.S. patent application Ser. No. 11/420,023 (U.S.Patent Application Publication No. 2006/0271153), filed on May 24, 2006;U.S. patent application Ser. No. 12/490,285 (U.S. Patent ApplicationPublication No. 2009/0318947), filed on Jun. 23, 2010; U.S. patentapplication Ser. No. 12/425,604 (U.S. Patent Publication No.2009/0287288), filed on Apr. 17, 2009; U.S. patent application Ser. No.12/425,617 (U.S. Patent Application Publication No. 2009/0287241), filedon Apr. 17, 2009; U.S. patent application Ser. No. 12/431,716 (U.S.Patent Application Publication No. 2009/0270974), filed on Apr. 28,2009; U.S. patent application Ser. No. 12/431,717, filed on Apr. 28,2009; U.S. patent application Ser. No. 12/431,721 (U.S. PatentPublication No. 2009/0292348), filed on Apr. 28, 2009; U.S. patentapplication Ser. No. 12/490,285 (U.S. Patent Application Publication No.2010/0010624), filed on Jun. 23, 2009; U.S. patent application Ser. No.12/490,285 (U.S. Patent Publication No. 2009/0319017), filed on Jun. 23,2009; U.S. patent application Ser. No. 12/731,110, filed on Mar. 24,2010; and U.S. patent application Ser. No. 12/751,997, filed on Mar. 31,2010; each of which is incorporated herein by reference in its entirety.Other occluding devices, deployment devices, catheters, and deploymentmethods are also possible.

In some embodiments, the method includes monitoring the aneurysmpost-operatively to confirm occlusion of the aneurysm. In someembodiments, a doctor or other provider may determine that an occludingdevice, after implantation, is operating correctly based on observationthat full or partial occlusion of the aneurysm has occurred, for exampleusing the observation and/or determination techniques described herein.

According to certain embodiments, observation of at least partialocclusion of the aneurysm immediately after implantation of theoccluding device provides an indication that the occluding device isoperating correctly. As a result, prolonged monitoring of the patientafter implantation of the occluding device may not be necessary. In someembodiments, monitoring the aneurysm can include imaging the aneurysmthrough known imaging techniques to confirm that the aneurysm iscompletely or at least partially occluded. For example, imagingtechniques such as those utilizing fluoroscopy, CAT scans, X-rays, MRIs,or other suitable imaging techniques may be used to monitor theaneurysm.

In some embodiments, two-dimensional imaging is utilized to monitor theaneurysm during and/or after delivery of the device within the vessel.In some embodiments, three-dimensional imaging is utilized to monitorthe aneurysm. For example, imaging of the delivery can be monitoredduring advancement of the device in the vasculature, deployment of thedevice at the aneurysm, and after deployment of the device prior toinitiation of withdrawal of the delivery system. In some embodiments,contrast agent can be delivered during advancement of the device in thevasculature, deployment of the device at the aneurysm, and/or afterdeployment of the device prior to initiation of withdrawal of thedelivery system. The contrast agent can be delivered through the samecatheter used to deliver the occluding device, or through anothercatheter or device commonly used to delivery contrast agent. Forexample, the catheter may comprise a lumen extending from a positionoutside the patient to a position proximate to the site to be treated(e.g., via a Y-joint in a handle of the catheter), and the lumen can beused to deliver contrast agent, drugs, saline, etc. In certain suchembodiments, the lumen may be coaxial with the delivery lumen,side-by-side the delivery lumen, etc. In some embodiments, initiation ofwithdrawal of the delivery system can be based on results from imagingthe device and aneurysm following expansion of the device at theaneurysm. In some embodiments, the results obtained from the imaginginclude partial occlusion of the aneurysm, which results then provideindication that the device is promoting occlusion of the aneurysm.

Although rare, in some instances, occlusion may not occur with thedeployment of a single occluding device. In certain such instances,monitoring of the aneurysm and device following deployment of theoccluding device at the aneurysm can indicate whether partial occlusionis occurring. If partial occlusion does not occur, some embodimentsprovide for deployment of a second device within the first device tofurther promote occlusion within the aneurysm. Regardless of whether oneor multiple devices are deployed, upon confirmation that partialocclusion is occurring within the aneurysm, withdrawal of the deliverysystem can be initiated.

In some embodiments, other techniques may be used to determine whetherat least partial occlusion of the aneurysm has occurred. For example,blood flow into an aneurysm may be monitored after positioning of thedevice within the vessel to determine whether occlusion is occurring.Reduced blood flow into an aneurysm may be an indication that occlusionof the aneurysm is occurring. In some embodiments, radio-opaque markersor other suitable trackers may be used to enable or enhance themonitoring of the blood flow into an aneurysm. In some embodiments, thepressure of the blood flow into an aneurysm, or the pressure exerted onthe walls of the aneurysm may be monitored to determine if occlusion ofthe aneurysm is occurring. For example, reduced outward pressure beingexerted on the walls of the aneurysm, as determined from blood flowpatterns in the vessel distal the aneurysm measured by an endovasculartransducer, may indicate that at least partial occlusion is occurring.In some embodiments, the stiffness or the hardness of the aneurysm maybe measured to determine whether occlusion is occurring. For example,occlusion of the aneurysm may occur, leading to at least partialthrombosis within the aneurysm. As a result, the aneurysm may be stifferor harder, as determined by observing variance in pulsation, than itwould have been had occlusion not occurred.

The apparatus and methods discussed herein are not limited to thedeployment and use of an occluding device or stent within the vascularsystem but may include any number of further treatment applications.Other treatment sites may include areas or regions of the body such asorgan bodies. Modification of each of the above-described apparatus andmethods for carrying out the subject technology, and variations ofaspects of the disclosure that are apparent to those of skill in the artare intended to be within the scope of the claims. Furthermore, noelement, component or method step is intended to be dedicated to thepublic regardless of whether the element, component or method step isexplicitly recited in the claims.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the subject technology butmerely as illustrating different examples and aspects of the subjecttechnology. It should be appreciated that the scope of the subjecttechnology includes other embodiments not discussed in detail above.Various other modifications, changes and variations which will beapparent to those skilled in the art may be made in the arrangement,operation and details of the method and apparatus of the subjecttechnology disclosed herein without departing from the spirit and scopeof the subject technology as defined in the appended claims. Therefore,the scope of the subject technology should be determined by the appendedclaims and their legal equivalents. Furthermore, no element, componentor method step is intended to be dedicated to the public regardless ofwhether the element, component or method step is explicitly recited inthe claims. Underlined and/or italicized headings and subheadings areused for convenience only, do not limit the subject technology, and arenot referred to in connection with the interpretation of the descriptionof the subject technology. In the claims and description, unlessotherwise expressed, reference to an element in the singular is notintended to mean “one and only one” unless explicitly stated, but ratheris meant to mean “one or more.” In addition, it is not necessary for adevice or method to address every problem that is solvable by differentembodiments of the disclosure in order to be encompassed by the claims.

What is claimed is:
 1. A method of treating an aneurysm at a junction ofa bifurcation having an afferent vessel and first and second efferentvessels, the method comprising: anchoring, in the first efferent vessel,a distal section of a stent while in an expanded configuration;anchoring, in the afferent vessel, a proximal section of the stent whilein the expanded configuration; and positioning a protruding section ofthe stent while in the expanded configuration to abut an ostium of theaneurysm on a side of the aneurysm that is adjacent to the secondefferent vessel, wherein, while in the expanded configuration, a maximumcross-sectional dimension of the protruding section is greater than amaximum cross-sectional dimension of the proximal section and a maximumcross-sectional dimension of the distal section.
 2. The method of claim1, further comprising positioning the protruding section to abut theostium of the aneurysm on a side of the aneurysm that is adjacent to thefirst efferent vessel.
 3. The method of claim 1, wherein the aneurysm islocated between the first and second efferent vessels.
 4. The method ofclaim 1, wherein the proximal section defines a proximal lumen, thedistal section defines a distal lumen, and the protruding sectiondefines an intermediate lumen, and wherein, after the positioning, theproximal, intermediate, and distal lumens provide a substantiallyunobstructed path for fluid flow from the afferent vessel to the firstefferent vessel and a strut pattern of the protruding section permitsfluid flow to the second efferent vessel.
 5. The method of claim 1,wherein at least one of the proximal, distal, and protruding sections isself-expanding.
 6. The method of claim 1, further comprising insertingembolic material into the aneurysm.
 7. The method of claim 1, wherein,while in the expanded configuration, first cells of the proximal sectionand/or the distal section have a first cell size that is substantiallyequal to a second expanded cell size of the second cells of theprotruding section.
 8. The method of claim 1, wherein the protrudingsection has a strut pattern that is substantially the same as a strutpattern of the proximal section and/or the distal section.
 9. The methodof claim 1, wherein the stent comprises filaments, and at least aportion of the protruding section has a lower filament density thanother portions of the protruding section to allow perfusion to thesecond efferent vessel.
 10. A method of treating an aneurysm at ajunction of a bifurcation having an afferent vessel and first and secondefferent vessels, the method comprising: providing a stent in acompressed configuration within a catheter, the stent comprising (i) aproximal section, (ii) a distal section; and (iii) a protruding section,between the proximal and distal sections; expanding the stent from thecompressed configuration to an expanded configuration out of thecatheter, the expanding comprising: anchoring, in the first efferentvessel, the distal section; anchoring, in the afferent vessel, theproximal section; and positioning the protruding section to abut anostium of the aneurysm on a side of the aneurysm that is adjacent to thesecond efferent vessel, wherein, while in the expanded configuration, amaximum cross-sectional dimension of the protruding section is greaterthan a maximum cross-sectional dimension of the proximal section and amaximum cross-sectional dimension of the distal section.
 11. The methodof claim 10, wherein the expanding further comprises positioning theprotruding section to abut the ostium of the aneurysm on a side of theaneurysm that is adjacent to the first efferent vessel.
 12. The methodof claim 10, wherein the aneurysm is located between the first andsecond efferent vessels.
 13. The method of claim 10, wherein theproximal section defines a proximal lumen, the distal section defines adistal lumen, and the protruding section defines an intermediate lumen,and wherein, after the expanding, the proximal, intermediate, and distallumens provide a substantially unobstructed path for fluid flow from theafferent vessel to the first efferent vessel and a strut pattern of theprotruding section permits fluid flow to the second efferent vessel. 14.The method of claim 10, wherein at least one of the proximal, distal,and protruding sections self-expands during the expanding.
 15. Themethod of claim 10, further comprising inserting embolic material intothe aneurysm.
 16. The method of claim 10, wherein, while in thecompressed configuration, first cells of the proximal section and/or thedistal section have a first compressed cell size greater than a secondcompressed cell size of second cells of the protruding section, andwherein, while in the expanded configuration, the first cells have afirst expanded cell size that is substantially equal to a secondexpanded cell size of the second cells.
 17. The method of claim 10,wherein the protruding section has a strut pattern that is substantiallythe same as a strut pattern of the proximal section and/or the distalsection.
 18. The method of claim 10, wherein the stent comprisesfilaments, and at least a portion of the protruding section has a lowerfilament density than other portions of the protruding section to allowperfusion to the second efferent vessel.